2013 expert panel new practice recommendations...prevention and health promotion administration 2014...
TRANSCRIPT
2013 Expert Panel
New Practice Recommendations
Nancy Baruch, RN, MBA
Center for TB Control and Prevention
Maryland Department of Health and Mental Hygiene
Prevention and Health Promotion Administration
Prevention and Health Promotion Administration
2014
2
2013 Expert Panel New Practice Recommendations
Maryland TB Expert Panel November 25, 2013
Discussion based on CTBCP review of published
research, published guidelines and
recommendations, and review of other state
practices by CTBCP staff regarding topics put
forward by CTBCP, LHD and Corrections staff.
Members included MD partners and TB experts
from State, LHDs, Corrections, TBESC and JHU.
Prevention and Health Promotion Administration
2014
3
2013 Expert Panel New Practice Recommendations
Agenda Topics
– Diabetes Screening
– Therapeutic Drug Monitoring
– Using video/mobile devices for DOT
– Use of IGRAs
– Bedaquiline
– LTBI Screening in Corrections
– Counting Doses during Intensive Tx. Phase
Prevention and Health Promotion Administration
2014
4
2013 Expert Panel New Practice Recommendations
Diabetes (DM) Screening
Prevention and Health Promotion Administration
2014
5
2013 Expert Panel New Practice Recommendations
General Facts Re: Diabetes and TB
Diabetes Mellitus, especially Type 2 DM,
is increasing worldwide
– WHO estimated in 2010 that 285 million
individuals worldwide were affected with DM
and projected ↑ to ~ 438 million by 2030
– DM disproportionately affects those also at
greater risk for acquiring tuberculosis lower socioeconomic status
ethnic minorities/foreign-born (12%-32%)
≥ 45 year age group with 22% among those ≥65
years
Prevention and Health Promotion Administration
2014
6
2013 Expert Panel New Practice Recommendations
General Facts RE: Diabetes and TB
The risk for developing active TB if
infected for person with DM is 2-3 times
more than non-DM
DM in Maryland:
– Affects 14% of TB cases vs. 9-11% of
general population
– 8% of TB-DM cases also have renal failure
– DM in Maryland has doubled since 2003
(4-5%) vs. 2009 (9-11%)
Prevention and Health Promotion Administration
2014
7
General Facts RE: Diabetes and TB
TB can worsen glycemic control complicating
management of diabetes
TB-DM patients who smoke >1 pack/day have
5.8 times increased risk of death vs. non-DM,
non-smoker
DM (especially uncontrolled) is associated with
poor TB treatment outcomes
– Treatment failure, relapse, and death
– Slower times to culture conversion (5-12 days)
– Reduced Rifampin concentration
2013 Expert Panel New Practice Recommendations
Prevention and Health Promotion Administration
2014
8
Recommendations for DM Screening
● Applies to all TB patients/suspects on treatment
● Screen for DM, using blood glucose or glycemic
control (HgA1c) at the time of treatment initiation
– For known diabetic (medical record/self-report):
Review existing HgA1c level
– For all others: Suspect DM if FBG ≥ 126 mg/dl;
“casual” BG ≥ 200 mg/dl; or HgA1c >6.5%
2013 Expert Panel New Practice Recommendations
Prevention and Health Promotion Administration
[Date]
9
2013 Expert Panel New Practice Recommendations
Recommendations for DM Screening (2)
● If no HgA1c, consider obtaining HgA1c on
known/suspected DM patient
● If HgA1c >7.0%:
– perform therapeutic drug monitoring
within 2-3 weeks of treatment initiation
– refer known or suspected diabetics for DM
evaluation and linkage to appropriate
medical care /case management
Prevention and Health Promotion Administration
2014
10
2013 Expert Panel New Practice Recommendations
Therapeutic Drug Monitoring (TDM)
Prevention and Health Promotion Administration
2014
11
2013 Expert Panel New Practice Recommendations
Therapeutic Drug Monitoring: Yes???
● Some TB patients are at higher risk for mal-
absorption of medications, including those with:
‒ co-morbidities such as HIV and DM
‒ MDR-TB
● Delayed time to culture conversion (> 2 months)
may be an initial sign of a malabsorption problem
● Knowing drug levels allows for early changes in
regimen and ↓ chances of resistance or relapse
Prevention and Health Promotion Administration
2014
12
2013 Expert Panel New Practice Recommendations
Therapeutic Drug Monitoring: No???
● Cost: ~ $80 per drug
● Unlikely to benefit most TB patients as tx. failure
and relapse are not common
● Multiple Test Options (2 hour vs.6 hour testing)
‒ 2 hour testing is the standard
‒ 6 hour testing can differentiate slow absorption
from malabsorption
Prevention and Health Promotion Administration
2014
13
2013 Expert Panel New Practice Recommendations
Recommendations for TDM
● Consider performing TDM for TB patients
when at least one of the following conditions
is met:
– Known diabetic with HgA1c >7.0%
– Severe TB disease
– Suspected Treatment Failure or Relapse:
defined for this purpose as delayed clinical or microbiological response to treatment (e.g., > 2 months sputum culture conversion)
Prevention and Health Promotion Administration
[Date]
14
2013 Expert Panel New Practice Recommendations
Recommendations for TDM (2)
● If HgbA1c >7.0%:– perform TDM within 2-3 weeks of treatment initiation
● Perform 2 hour test unless otherwise
requested by TB consultant
● Dosage changes based on TDM should be made in consultation with a TB expert
● Refer known or suspected diabetics for DM
evaluation and linkage to appropriate medical care/case management
Prevention and Health Promotion Administration
[Date]
15
2013 Expert Panel New Practice Recommendations
Recommendations for TDM (3)
● Submit blood to an approved TDM lab
● High TB burden jurisdictions should have staff certified to perform and submit blood for TDM directly to approved lab to reduce risk of a poor, inadequate, or late sample
● Low burden jurisdictions should submit blood
for drug levels to the DHMH TB Lab for shipment per policy
● Dosage changes based on TDM results should be made in consultation with TB Expert and CTBCP
Prevention and Health Promotion Administration
[Date]
16
2013 Expert Panel New Practice Recommendations
Recommendations for TDM (4)
● Policy becomes effective immediately and will be incorporated into revised MD guidelines
● DHMH 2014 TDM Workgroup Members:
Deb Hardy, HCHD, Ann Inman, PGCHD, Rich Oatis, DHMH Lab., Andrea Palmer, CTBCP, Sherry Roberts, BCHD, Jafar Razeq. DHMH Lab., Kimberly Townsend, MCHD, Kay Tremeloni, PGCHD
Prevention and Health Promotion Administration
2014
17
2013 Expert Panel New Practice Recommendations
Video Directly Observed Therapy
(vDOT)
Prevention and Health Promotion Administration
2014
18
2013 Expert Panel New Practice Recommendations
Video DOT (vDOT) : Why ????
Directly Observed Therapy (DOT) is the standard
of care for providing medications to TB patients
Endorsed by WHO, recommended by CDC and
codified via regulation in MD (MD COMAR 10.06.01)
– Resource intensive
– Reduced funding in public health necessitates
evaluating new cost-effective options to DOT
vDOT offers a flexible, cost effective option to
provide DOT using available (and future)
technologies
Prevention and Health Promotion Administration
2014
19
2013 Expert Panel New Practice Recommendations
Recommendations for vDOT
● vDOT is an approved method of DOT in Maryland
based on the following criteria
− Patients receiving care under LHD supervision
– Excluded for MDR or XDR TB unless approved
by CTBCP (requires formal consultation)
– Patient/guardian must be capable of and
demonstrate understanding of tx. plan and
handling of video/electronic equipment
– Demonstrate compliance with treatment plan
Prevention and Health Promotion Administration
2014
20
2013 Expert Panel New Practice Recommendations
Recommendations for vDOT (2)
Demonstration of Compliance
– 100% cooperation with in-person DOT for
the intensive phase of treatment before
moving to vDOT
Daily dosing 7 days per week X 2 weeks
Daily dosing 5 days per week X 3 weeks
– A minimum of 80% DOT compliance for
remainder of treatment (evaluated weekly) OR
– Approval from CTBCP
Prevention and Health Promotion Administration
2014
21
2013 Expert Panel New Practice Recommendations
Recommendations for vDOT (3)
Live visual contact time preferable if possible, but
if not, review videos/recordings no less than
once a week with patient
Local TB policy must conform with Expert Panel
recommendations and must be reviewed and
approved by LHD administration; review annually
Local TB program will monitor and remove any
patient from participation for noncompliance
Document on RVCT as DOT, unless outside
standards for vDOT compliance
Prevention and Health Promotion Administration
2014
22
2013 Expert Panel New Practice Recommendations
Recommendations for vDOT (4) Age limits: Determined on case-by-case basis
– LHD should obtain signed parental/guardian
permission for children ≤ 18 years of age who
will self vDOT
– Signed agreement should be considered for
parents who use vDOT to administer meds to
own children
Use of packets: Determined on case by case
basis with CTBCP review if for ≥ 2 weeks
Prevention and Health Promotion Administration
2014
23
2013 Expert Panel New Practice Recommendations
Recommendations for vDOT (5)
● vDOT workgroup is in process of developing
MD policy which will be incorporated into new
guidelines
● Until policy is final, please consult with CTBCP
prior to using vDOT
● Current vDOT workgroup members include:
Maureen Donovan, CTBCP, Bonnie Lewis,
Caroline Co., Barb Johnson/Maunank Shah,
Baltimore City, Kimberly Townsend, Mont Co.
and Jayne McGunigale, Howard Co.
Prevention and Health Promotion Administration
2014
24
2013 Expert Panel New Practice Recommendations
IGRA’s :
“Confirmatory “ Tests ???
and
OK for Children ≤ 5 years ???
Prevention and Health Promotion Administration
2014
25
2013 Expert Panel New Practice Recommendations
General Facts Re: Using IGRAs as
Confirmatory Tests
A positive TST followed by negative IGRA
does NOT necessarily rule out TB infection
Treatment must be considered in those groups
at high risk for TB infection
Treatment of TB infection is critical to
decreasing the pool of future active cases
Prevention and Health Promotion Administration
2014
26
2013 Expert Panel New Practice Recommendations
Revised Recommendations RE: Using
IGRAs as Confirmatory Tests
● Select one or the other FDA approved test (IGRA or TST)
based on population risk and test that is available at LHD
● Routine use of an IGRA as a ‘confirmatory’ test for a
positive TST should not be done in individuals at high risk
for progression to disease; close contacts. immigrants
and refugees with TB Class B waivers, other individuals
at high risk for infection
Prevention and Health Promotion Administration
2014
27
2013 Expert Panel New Practice Recommendations
Use of IGRAs in Children ≤ 5 years of age
IGRAs are more problematic in children <5 yrs old
– Failed T-SPOT TB more common (<4.7 years)
– Indeterminate QFT results more common (11% or 14 of
127) in children 0-5 years)
Very little published data and numbers are small
More discordant results may be related to:
– Effects of BCG vaccine
– Functional status of immune system
– Nature of pediatric TB infection
Prevention and Health Promotion Administration
2014
28
2013 Expert Panel New Practice Recommendations
Recommendations RE: Use of IGRAs in
Children ≤ 5 years of age
● Do not routinely use an IGRA for children
younger than 5 years old
● Consult with CTBCP or TB Expert prior to
use in young children
Prevention and Health Promotion Administration
[Date]
29
Screening for TB infection in
Correctional Facilities
Prevention and Health Promotion Administration
2014
30
2013 Expert Panel New Practice Recommendations
Screening for TB infection in Correctional
Facilities
●TB remains a significant problem in correctional facilities
due to close quarters and close proximity of inmates
Maryland Data:
● In 2012, over 21,000 individuals were incarcerated in MD
state and federal facilities
● 5 MD counties (predominantly rural) house ICE detainees
(numbers vary from year to year)
Prevention and Health Promotion Administration
2014
31
2013 Expert Panel New Practice Recommendations
Screening for TB infection in Correctional
Facilities
● Between 2009-2012, there were 9 active TB
cases among inmates in MD facilities
– 8 in local detention centers
– 1 in a federal facility
● 2009 Expert Panel approved concept of minimal
and non-minimal risk definitions as applied to
screening and testing for TB in correctional
facilities
Prevention and Health Promotion Administration
[Date]
32
2013 Expert Panel New Practice Recommendations
2013 Recommendations RE: Screening for
TB infection in Correctional Facilities
● Minimal risk facilities (defined as facilities in
jurisdictions with no cases for ≥ one year):
– Use full TB risk screening tool for everyone
– Test for TB anyone who answers "YES" to
any question indicating ↑ risk for TB
● Non-minimal risk facilities:
– follow CDC guidelines; Prevention and Control of
Tuberculosis in Correctional and Detention
Facilities: Recommendations from CDC; MMWR
2006;55(No. RR-9) http://www.cdc.gov/mmwr/PDF/rr/rr5509.pdf
Prevention and Health Promotion Administration
[Date]
33
2013 Expert Panel New Practice Recommendations
Screening for TB infection in Correctional
Facilities: 2013 Recommendations (2)
● Non-Minimal Risk Facilities:Repeat offenders
− Use symptom/risk assessment tool for repeat
offenders within same year (12 months) who have
documented history of positive TST or IGRA and
negative CXR
− Test those who answer "YES" to any high risk TB
question during risk screening; CXR and medical
evaluation required for those whose assessment
has changed or who present with TB symptoms
− Yearly CXR is not needed if symptom screen negative
Prevention and Health Promotion Administration
[Date]
34
2013 Expert Panel New Practice Recommendations
Bedaquiline for TB Treatment
Prevention and Health Promotion Administration
2014
35
2013 Expert Panel New Practice Recommendations
Bedaquiline (BDQ) for TB Treatment
● The first new class of drugs to obtain FDA
approval for a TB indication in 40 years (December 2012)
● Indicated as part of combination therapy in adults >18 years of age with pulmonary MDR-TB
● Drug has a half-life of approximately 5.5 months
● Single regimen costs ~$23,000
Prevention and Health Promotion Administration
2014
36
2013 Expert Panel New Practice Recommendations
Bedaquiline (BDQ) for TB Treatment
● The recommended dose of Bedaquiline for the treatment of pulmonary MDR in adults:
– 400 mg given orally once daily for 2 weeks
– followed by 200 mg orally three times weekly with a total treatment duration of 24 weeks
● Concerns– Prolonged QT interval on EKG
– Death risk after discontinuation due to long half-life
Prevention and Health Promotion Administration
2014
37
2013 Expert Panel New Practice Recommendations
Recommendations RE: Bedaquiline for TB Treatment
● Add to Maryland TB Guidelines
● Use must be approved through CTBCP before drug can be ordered according to both manufacturer and CDC protocols
● Approval for use is based on CDC provisional guidelines, on a case-by-case basis, when an effective treatment regimen is not otherwise available
● Outcomes of all patients on BDQ will be systematically monitored
Prevention and Health Promotion Administration
2014
38
2013 Expert Panel New Practice Recommendations
Counting Doses/Weeks for
Completion of Initiation Phase of
TB Treatment
Prevention and Health Promotion Administration
2014
39
2013 Expert Panel New Practice Recommendations
Counting Doses /Weeks for Completion of Initiation Phase of TB Treatment
● Confusion with current MD Guidelines over how to count doses/weeks when determining completion of initiation phase of TB tx.
● 2 options for starting TB treatment:– Daily dosing X 7 days per week X 2 weeks
– Daily dosing X 5 days per week X 3 weeks
● Initiation phase then continues for 6 weeks
● When is initiation phase of treatment technically over ?
Prevention and Health Promotion Administration
2014
40
2013 Expert Panel New Practice Recommendations
Recommendations RE: Counting Doses /Weeks to
Determine Completion of Initiation Phase
● Initiation phase of treatment is defined as a total
of 8 weeks regardless of regimen chosen for
first 14 or 15 days of intensive treatment
● Daily dosing during the first 14 or 15 doses of
treatment (depending on regimen selected) does
NOT include counting of weekend packets
● Initiation phase of treatment is followed by 4
month continuation phase
Prevention and Health Promotion Administration
2014
41
2013 Expert Panel New Practice Recommendations
NEXT STEPS
● Recommendations as presented can be put
in place by local programs effective
immediately; except for vDOT which requires
consultation with CTBCP until procedure is
finalized
● Recommendations are in the process of
being incorporated into MD guidelines for
publication; members from this audience
may soon be asked to assist in final review
and editing….stay tuned!
Prevention and Health Promotion Administration
[Date]
42
Maryland TB Expert Panel 2013
Akintoye Adelakun, MD, MS, PGCHD
Karla Alwood, CRNP, BCHD,
Johns Hopkins School of Medicine
Nancy Baruch, RN, MS, MBA, DHMH
Sharon Baucom, RN, MD, DPSCS
David Blythe, MD, MPH, DHMH
Sarah Bur, RN, MPH, Fed. Bureau of
Prisons
Richard Chaisson, MD, JHU Sch. Med.
Patrick Chaulk, MD, MPH, BCHD
Wendy Cronin, PhD, MS , DHMH
Maureen A. Donovan, RN, MA, DHMH
Kelly Dooley, MD, PhD, JHU Sh..Med.
Susan Dorman, MD, JHU Sch. Med.
Jacqueline Douge’, MD, FCHD
Bernard Farrell, MD, HCHD
Itala Fontana, RN, MCHD
Cathy Goldsborough, RN, BSN, DHMH
Jonathan Golub, PhD,MPH, JHU Sch.Med.
Mark Hodge, RN, MS, MCHD
Eric Nuermberger, MD, JHU Sch. Med.
Rich Oatis, BS, DHMH Laboratory Adm.
Andrea Palmer, MA, DHMH
Lisa Paulos, RN, MPH, DHMH
Sonia Qasba, MD, MPH, MCHD
Adaora Odunze, RN, MS, PhD, DPSCS
William Randall, MD, DHMH
Jafar Razeq, PhD, DHMH Laboratory Adm.
Sherry Roberts, RN, BCHD
Brenda Roup, RN, PhD, CIC, DHMH
Kelly Russo, MD, MPH, AACHD
Maunank Shah, MD, PhD, BCHD
Thomas Walsh, MD, MCHD
Walter Karney, MD, PGCHD
Danielle Weber, RN, MS, SCHD
Lucy Wilson, MD, ScM, DHMH
http://phpa.dhmh.maryland.gov
Prevention and Health Promotion Administration
[Date]
43
PREVENTION AND
HEALTH PROMOTION
ADMINISTRATION